Cleared Special

K192661 - LATERA Absorbable Nasal Implant System (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192661 · Entellus Medical, Inc. (Aka Stryker Ent) · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 2019
Decision
46d
Days
Class 2
Risk

K192661 is an FDA 510(k) clearance for the LATERA Absorbable Nasal Implant System. Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by Entellus Medical, Inc. (Aka Stryker Ent) (Plymouth, US). The FDA issued a Cleared decision on November 10, 2019 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Entellus Medical, Inc. (Aka Stryker Ent) devices

Submission Details

510(k) Number K192661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2019
Decision Date November 10, 2019
Days to Decision 46 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 89d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
Definition Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.